RFI USPTO Public Campaign Strategy.pdf

United States Patent and Trademark Office (USPTO) Public Awareness

Campaign Strategy on the dangers of counterfeit substances or devices

REQUEST FOR INFORMATION (RFI)

United States Patent and Trademark Office (USPTO) Public Awareness campaign strategy on the dangers of counterfeit substances or devices

THIS IS A PTAG SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY.

In accordance with the Patent and Trademark Office Efficiency Act (PTOEA), 35 U.S.C. § 2(b)(4)(A), this Sources Sought Notice Request for Information) (RFI) is strictly for market research ONLY. It is for informational and planning purposes and shall NOT be construed as a solicitation or as an obligation or commitment by the Government at this time.

Patent and Trademark Office Efficiency Act (PTOEA) Procurement:

The Government contemplates utilizing the Alternative Competition Method in accordance with the Patent and Trademark Office Acquisition Guidelines (PTAG) and the Patent and Trademark Office Efficiency Act 35 U.S.C. 2(b)(4)(A). This Sources sought notice is intended as preliminary market information gathering which the United States patent and Trademark Office (USPTO) will use to determine which contractor(s) is/are the most likely to successfully meet the agency’s needs and are thereby eligible to participate in an alternative competition. As a result of this market research, the solicitation will only be issued to the/ those qualified small business contractor(s) that is/are deemed most likely to successfully meet the agency’s requirements as stated below.

This RFI is being made available under NAICS 541820 - Public Relations Agencies.

1. Background

The USPTO is a federal agency in the Department of Commerce (DOC), which is headquartered in Alexandria, VA. The mission of the USPTO is to foster innovation and competitiveness by providing high quality and timely examination and issuance of patent and trademark applications, guiding domestic and international intellectual property policy, and delivering intellectual property information and education worldwide.

Through the issuance of patents, the USPTO encourages technological advancement by providing incentives to invent, invest in, and disclose new technology worldwide. Through the registration of trademarks, the agency assists businesses in protecting their investments, promoting goods and services, and safeguarding consumers against confusion and deception in the marketplace. The office employs over 13,000 full-time staff to support its work.

2. Objectives

The USPTO is seeking information from qualified vendors regarding capabilities and relevant experience to support potential public relations services to create and execute a nationwide public awareness campaign consisting of media relations, videos, and other creative communications deliverables including a microsite and social media campaign to highlight the dangers of counterfeit pharmaceuticals and medical devices that are falsely represented as products made or distributed by real pharmaceutical and medical device companies.

3. Abbreviated Scope of Work

This effort is for campaign services to support a nationwide public awareness campaign to highlight the dangers of counterfeit pharmaceuticals and medical devices.

A counterfeit is defined pursuant to Title 18 of the U.S. Code, Chapter 25 as “the fraudulent copy of money, documents, designer pieces, or other valuable items. The counterfeiter often provides these goods to others with an intent to defraud.”

Title 18 of the U.S. Code, Chapter 2320(f)(1) defines a counterfeit mark as a “spurious mark— (i) that is used in connection with trafficking in any goods, services, labels, patches, stickers, wrappers, badges, emblems, medallions, charms, boxes, containers, cans, cases, hangtags, documentation, or packaging of any type or nature; (ii) that is identical with, or substantially indistinguishable from, a mark registered on the principal register in the United States Patent and Trademark Office.”

Under the Federal Food, Drug, and Cosmetic Act, the term “counterfeit” is defined in section 201(h)(2). It applies specifically to devices and is used in the context of the Act’s enforcement provisions. Under 21 U.S.C. § 321, a counterfeit device is defined as “a device that is not the same as the device it purports to be — meaning it is not the genuine article that the manufacturer or seller claims it to be. This can include devices that are replicas, imitations, or altered versions of an approved device, or that are manufactured without authorization and presented as an authentic product.”

Finally, Title 21 of the United States Code, Section 802 defines a “counterfeit substance” as any controlled substance whose container, labeling, or physical form bears the trademark, trade name, imprint, number, or identifying mark of a legitimate manufacturer, distributor, or dispenser without that company’s authorization.”

The key focus of the potential public awareness campaign is to create and execute a campaign that highlights the dangers of purchasing counterfeit pharmaceuticals and medical devices. Respondents are expected to provide evidence of their experience creating and executing successful campaigns in the pharmaceutical and medical device sectors with these specificities in mind.

Potential areas of interest may include:

• Develop a campaign strategy.

• Assist with development, writing and editing of educational materials, blogs, press releases and other public-facing written elements related to the campaign.

• Develop and distribute public service announcements and campaign materials.

• Create and execute materials to amplify the messaging of the campaign including digital marketing/media.

• Identify and pitch key individuals (influencers, celebrities, journalists) to cover and promote the campaign.

• Work with USPTO to house relevant facts, visuals, campaign materials and other useful data on a microsite identified by OPIA.

• Work with OPIA staff to determine appropriate metrics and distribution for successful roll-out and execution of the campaign.

4. Requested Information

Respondents should address all 9 questions:

1) Company Overview and Experience Provide a brief overview of your company, including its core capabilities, primary lines of business, and relevant experience.

2) Organization Size and Locations Identify your organization’s size, principal place of business, and the locations of your employees or operational teams that would support this effort.

3) Capabilities and Limitations Identify any functions described in this RFI that your organization would be unable to perform. For each such function, explain the limitation and identify whether you would rely on subcontractors, partners, or other resources.

4) Experience with developing campaigns for the pharmaceutical or medical industries focused on counterfeit pharmaceuticals or medical devices, for both commercial and government organizations.

a) Describe any prior directly relevant experience. Identify the organizations, dates or periods of performance, and the capacity in which you provided services. Include dollar value and date of prior services.

b) Have you worked with clients in the pharmaceutical or medical devices industry?

1. Describe the services and/or product solution(s) for the areas described.

2. The responses must include an overall description of the services and/or solution(s) and provide technical data and a demonstrated ability for those areas identified.

3. Are the individuals who worked on these accounts currently still engaged in this field within your agency?

4. Provide information to demonstrate knowledge, skills and expertise.

5) Experience with developing campaigns for the pharmaceutical and medical devices industries. Provide information about the specific campaigns, including the size, complexity and scope. Information should be pertinent and specific, including media vehicle strategy.

a) Do you have a network of decision-makers, stakeholders, or influencers in this space?

b) Describe the distribution model typically employed for this type of campaign.

6) Recommended Outreach Methods and Channels Identify the outreach methods and communication channels you would recommend for reaching a general audience. Examples may include social media, digital advertising, events, educational programming, media outreach, and community or institutional partnerships.

7) Personnel and Subject-Matter Expertise Describe the in-house personnel, functional resources, and subject-matter expertise needed to successfully perform this work that would manage this potential project.

Identify any anticipated key personnel roles, specialized capabilities, or subcontractor support.

Please identify the use of:

• Existing technologies or resources.

• Improvements/enhancements.

• Cost efficiencies of your specific approach.

• Any other support capabilities that provide service and/or product excellence.

8) Performance Metrics and Evaluation Describe the performance measures you would recommend in order to evaluate the effectiveness of this type of outreach initiative, such as reach, engagement, participation, stakeholder partnerships, audience awareness, or other relevant outcomes.

a) What data and analytics do you rely on to guide your campaigns?

b) How do you measure success beyond media creation and placements?

c) Do you have case studies or campaign results that demonstrate success?

9) Potential Risks and Mitigation Strategies Identify any significant legal, reputational, operational, scheduling, or stakeholder-related risks associated with this type of outreach effort and describe how your organization would mitigate those risks.

5. Response Requirements

Responses should include the following 4 areas below:

1. Capability Statement The capability statement should include a detailed response to the requested information above. Respondents may provide relevant examples, case studies, client references, or publicly available supporting materials, as appropriate.

2. Company Information o Legal name of the firm o Commercial and Government Entity (CAGE) Code, if available o SAM.gov Unique Entity ID (UEI), if available o Primary place of business o Business size and socioeconomic status, if applicable o Identification of whether the firm qualifies as a small business o GSA Schedule contract number(s), if applicable

3. Primary Contact Information o Name and title o Complete mailing address o Email address o Telephone number

4. Relevant Contract or Project Examples

For each example, provide, if available:

o Client or sponsoring organization o Contract or project title o Period of performance o Brief description of work performed o Approximate contract or project value o Description of the respondent’s role and responsibilities

6. Submission Instructions

Responses should be submitted electronically in searchable PDF format to:

Point of Contact: Emalee Gawrelski and Joy Pitts

Email: Emalee.Gawrelski@uspto.gov and Joy.Pitts@uspto.gov mailto:Emalee.Gawrelski@uspto.gov mailto:Joy.Pitts@uspto.gov

Questions due: Any questions regarding this RFI must be submitted no later than October 26, 2026 at 1pm ET to Emalee.Gawrelski@uspto.gov and Joy.Pitts@uspto.gov

RFI Response Due Date: November 6, 2026 10am ET RFI Reference: OPIA RFI on dangers of counterfeit substances or devices

Responses should be concise and should not exceed 5 pages in total, excluding cover pages and relevant attachments. Respondents should clearly identify any information they consider proprietary or confidential. However, respondents should not submit information that is personally identifiable, sensitive, export-controlled, classified, or otherwise restricted.

5. Important Notice

SAM.gov registration is not required to submit an RFI response, but current registration will be required if the USPTO proceeds with a procurement. Offerors or quoters are required to have an active Federal Government contracts registration in SAM.gov when they submit an offer or quotation, and at the time of award. See Revolutionary FAR Overhaul (RFO) 4.203 System for Award Management. Submission of a response does not create an obligation for the Government to award a contract, issue a solicitation, reimburse preparation costs, or provide feedback. The Government may contact respondents for additional information.

Information provided may be used to develop acquisition strategies, market research, statements of work, and future solicitation requirements.

mailto:Emalee.Gawrelski@uspto.gov https://sam.gov/entity-registration